Emilie E. Kahn
Consumer Safety Officer, JD, MPH
ORA (Northeast/Mid-Atlantic Region)
Legally trained investigator who founded FDA's Women Investigators Network (WIN) — brings JD and MPH credentials to inspections of generic manufacturers, compounding pharmacies, and international facilities across 4 countries.
Inspection Approach
How Emilie Inspects
Kahn's dual legal and public health training gives her a distinctive inspection approach that combines scientific rigour with regulatory precision. Her JD background is evident in the thoroughness of her documentation and her focus on whether firms can legally defend their testing and manufacturing practices.
Her inspection history spans generic pharmaceutical manufacturers like Lannett Company to compounding pharmacies like University Compounding Pharmacy in Michigan, where she identified sterile compounding deviations that were referred to the Michigan Board of Pharmacy. At Grato Holdings, she cited the fundamental failure to establish accuracy, sensitivity, specificity, and reproducibility of test methods — a foundational analytical requirement.
Beyond her inspection work, Kahn founded the Women Investigators Network (WIN) in March 2022, now 300+ members across FDA ORA, indicating significant influence within the agency. Her international inspection experience across the UK, South Korea, and Germany demonstrates capability with diverse regulatory environments.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Diversified Pharmacy Inc dba University Compounding Pharmacy
- Sterile compounding deviations observed during aseptic processing operations
- Findings related to aseptic processing practices that could lead to contamination of sterile products
- Referred to Michigan Board of Pharmacy for additional regulatory action
Lannett Company, Inc.
- Generic pharmaceutical manufacturing deficiencies identified during inspection
- Quality system and production control observations
Grato Holdings, Inc.
- The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established
- Fundamental analytical method validation requirements not met for product testing
Pre-Inspection Preparation
How to Prepare
- 1 Ensure all test methods are fully validated for accuracy, sensitivity, specificity, reproducibility, and ruggedness before use in product testing.
- 2 Document method transfers from contract laboratories with matching sample testing at both sites.
- 3 Review sterile compounding practices against USP <797> and FDA guidance for aseptic processing.
- 4 Verify aseptic technique training, qualification, and monitoring documentation for all personnel.
- 5 Ensure quality unit procedures are written, current, and demonstrably followed — not just documented.
- 6 Maintain contemporaneous, complete, and accurate records across all operations.
- 7 Review environmental monitoring programmes for adequacy of sampling locations, frequencies, and trend analysis.
- 8 Verify component and raw material testing or supplier qualification programmes meet regulatory requirements.
- 9 For 503B outsourcing facilities: verify all regulatory requirements including labeling, adverse event reporting, and drug substance sourcing.
- 10 Given her legal background, ensure all regulatory submissions and 483 responses are legally precise and well-documented.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
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